Role of Dietary Habits in Efficacy of Bariatric Surgery - Study C
2 other identifiers
interventional
44
1 country
1
Brief Summary
The purpose of the study is to test how dietary habit interventions affect patients weight loss outcomes after bariatric surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2018
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedStudy Start
First participant enrolled
December 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
December 5, 2025
November 1, 2025
6.6 years
March 12, 2018
November 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post-intervention change in self-rated hunger
Differences in self-rated hunger as measured from the visual analogue scale (VAS; 0-100 score with 0 as ''not at all'' and 100 as ''very much''/''extremely'') questionnaire at baseline and after the intervention
Baseline and 4 weeks (post-intervention)
Secondary Outcomes (3)
Change in caloric intake
baseline and 4 weeks (post-intervention)
Change in energy expenditure
baseline and 4 weeks (post-intervention)
Change in glucose tolerance
baseline and 4 weeks (post-intervention)
Study Arms (2)
Group A
EXPERIMENTALSubject will be advised to follow dietary habits plan A. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.
Group B
EXPERIMENTALSubject will be advised to follow dietary habits plan B. Since this is a single blind study, the details of the dietary interventions cannot be released during recruitment stage, but will be made public once enrollment closes.
Interventions
Patients will be given a personalized plan regarding their diet.
Eligibility Criteria
You may qualify if:
- Bariatric surgery (sleeve gastrectomy) patients
You may not qualify if:
- Insulin-dependent diabetes
- Anemia
- Smoking
- Shift work within the past 1 year
- Drug or alcohol dependency
- Bipolar disorder
- Post traumatic stress disorder (PTSD)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frank Scheer, PhD
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
Ali Tavakkoli, MD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 12, 2018
First Posted
March 29, 2018
Study Start
December 7, 2021
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
December 5, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share